search
Back to results

Hatha Yoga in Improving Physical Activity, Inflammation, Fatigue, and Distress in Breast Cancer Survivors

Primary Purpose

Breast Cancer, Depression, Fatigue

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga Therapy
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring fatigue, depression, pain, cancer survivor, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, breast cancer in situ

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Stage 0-IIIA breast cancer survivor

  • Completed cancer treatment within the past 36 months (except for tamoxifen/aromatase inhibitors)

    • At least 2 months since prior surgery, adjuvant therapy, or radiotherapy, whichever occurred last

  • Women who are not currently practicing yoga and have not participated in any of the following activities:

    • Meditation, tai chi, or related activities
    • Yoga or tai chi within the past 6 months
    • Had classes for or practiced yoga for more than 3 months
  • Women who typically engage in a total of 5 or more hours of vigorous physical activity per week are not eligible
  • No inflammatory breast cancer

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • Hemoglobin ≥ 10 g/dL (patients with a hemoglobin of < 10 g/dL may be retested in 6 weeks after treatment of anemia and allowed to participate in study if blood counts recovered)
  • Physically able to fully participate in yoga intervention

Exclusion criteria:

  • Inability to comfortably get up and down from the floor 2-3 times in a session
  • Breathing problems requiring use of oxygen
  • Problems walking without a cane or walker assistance
  • Prior knee or hip replacement with limited movement in the joint
  • Inability to comfortably lie on the stomach
  • Alcohol, or drug abuse

  • Diagnosis of any of the following conditions:

    • Diabetes
    • Chronic obstructive pulmonary disease
    • Uncontrolled hypertension
    • Evidence of liver or kidney failure
    • Symptomatic ischemic heart disease
    • Significant visual or auditory problems
    • Mental disorder or cognitive impairment
    • Notable serious cardiovascular history (e.g., prior life-threatening abnormal heart rhythms)
    • Other medical conditions involving the immune system such as autoimmune and/or inflammatory diseases including rheumatoid arthritis and ulcerative colitis
  • History of breast or any other cancer, except basal or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No regular use of medications with major immunological consequences (e.g., steroids)

Sites / Locations

  • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm I: Yoga Therapy

Arm II: Wait-List

Arm Description

Patients participate in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients are also encouraged to practice yoga at home using the appropriate DVD/video segments for the month.

Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.

Outcomes

Primary Outcome Measures

Stimulated ln (TNF-a)
log-transformed Lipopolysaccharide (LPS) stimulated Tumor Necrosis Factor-alpha (TNF-alpha)
Stimulated ln (IL-6)
log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-6 (IL-6)
Stimulated ln (IL-1b)
log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-1 beta (IL-1b)
MFSI-SF Fatigue
The 30-item Multidimensional Fatigue Symptom Inventory-Short form (MFSI-SF) assesses behavioral, cognitive, physical, and affective expressions of fatigue. Items are rated on a 5-point scale indicating how true each statement was for the respondent during the last week (0=not at all; 4=extremely). The total score represents the sum of the subscales measuring general, physical, emotional, and mental fatigue, minus the vigor scale, providing a possible range of scores from -24 to 96, with higher scores indicating greater fatigue.
Vitality, SF-36
The SF-36's (RAND Health Survey) energy/fatigue (vitality) scale focuses on the frequency of feelings of fatigue over the last month. Standardized scores on the RAND SF-36 vigor/vitality scale range from 0-100, with higher scores indicating less fatigue.
CES-D
The Center for Epidemiological Studies Depression Scale (CES-D) is a self-report scale designed to measure current symptoms of depression rated on a four-point likert scale. Scores range from 0-60, with higher scores indicating a higher frequency of depressive symptoms.

Secondary Outcome Measures

Full Information

First Posted
June 13, 2007
Last Updated
April 17, 2014
Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00486525
Brief Title
Hatha Yoga in Improving Physical Activity, Inflammation, Fatigue, and Distress in Breast Cancer Survivors
Official Title
Breast Cancer Survivors: Physical Activity, Inflammation, Fatigue, and Distress
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Yoga may improve inflammation, fatigue, and depression in female breast cancer survivors. PURPOSE: This randomized clinical trial is studying how well Hatha yoga works in improving physical activity, inflammation, fatigue, and distress in female breast cancer survivors.
Detailed Description
OBJECTIVES: Primary To determine if the yoga intervention will decrease inflammation, fatigue, and depressive symptoms relative to the waiting-list controls in women who are stage 0-IIIa breast cancer survivors. OUTLINE: Patients are stratified according to stage of cancer (stage 0 vs stage I vs stage II and stage IIIA) and prior radiation therapy (yes vs no). Patients are randomized to 1 of 2 intervention arms. Arm I (waiting-list control): Patients are encouraged to perform usual activities, but asked to refrain from any yoga practice or other related activities. After a six-month observation period, patients undergo yoga intervention as described in arm II . Arm II (yoga intervention): Patients participate in a Hatha yoga intervention session comprising body postures and breath control techniques for 1.5 hours twice a week for 12 weeks. Patients are encouraged to practice Hatha yoga at home. Patients complete daily diaries on home Hatha yoga practices and submit them at each session.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Depression, Fatigue, Pain
Keywords
fatigue, depression, pain, cancer survivor, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, breast cancer in situ

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I: Yoga Therapy
Arm Type
Experimental
Arm Description
Patients participate in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients are also encouraged to practice yoga at home using the appropriate DVD/video segments for the month.
Arm Title
Arm II: Wait-List
Arm Type
No Intervention
Arm Description
Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
Intervention Type
Procedure
Intervention Name(s)
Yoga Therapy
Other Intervention Name(s)
Yoga
Intervention Description
Patients will undergo yoga therapy
Primary Outcome Measure Information:
Title
Stimulated ln (TNF-a)
Description
log-transformed Lipopolysaccharide (LPS) stimulated Tumor Necrosis Factor-alpha (TNF-alpha)
Time Frame
Immediately post-treatment and 3 months post-treatment
Title
Stimulated ln (IL-6)
Description
log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-6 (IL-6)
Time Frame
Immediately post-treatment and 3 months post-treatment
Title
Stimulated ln (IL-1b)
Description
log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-1 beta (IL-1b)
Time Frame
Immediately post-treatment and 3 months post-treatment
Title
MFSI-SF Fatigue
Description
The 30-item Multidimensional Fatigue Symptom Inventory-Short form (MFSI-SF) assesses behavioral, cognitive, physical, and affective expressions of fatigue. Items are rated on a 5-point scale indicating how true each statement was for the respondent during the last week (0=not at all; 4=extremely). The total score represents the sum of the subscales measuring general, physical, emotional, and mental fatigue, minus the vigor scale, providing a possible range of scores from -24 to 96, with higher scores indicating greater fatigue.
Time Frame
Immediately post-treatment and 3 months post-treatment
Title
Vitality, SF-36
Description
The SF-36's (RAND Health Survey) energy/fatigue (vitality) scale focuses on the frequency of feelings of fatigue over the last month. Standardized scores on the RAND SF-36 vigor/vitality scale range from 0-100, with higher scores indicating less fatigue.
Time Frame
Immediately post-treatment and 3 months post-treatment
Title
CES-D
Description
The Center for Epidemiological Studies Depression Scale (CES-D) is a self-report scale designed to measure current symptoms of depression rated on a four-point likert scale. Scores range from 0-60, with higher scores indicating a higher frequency of depressive symptoms.
Time Frame
Immediately post-treatment and 3 months post-treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Stage 0-IIIA breast cancer survivor Completed cancer treatment within the past 36 months (except for tamoxifen/aromatase inhibitors) At least 2 months since prior surgery, adjuvant therapy, or radiotherapy, whichever occurred last Women who are not currently practicing yoga and have not participated in any of the following activities: Meditation, tai chi, or related activities Yoga or tai chi within the past 6 months Had classes for or practiced yoga for more than 3 months Women who typically engage in a total of 5 or more hours of vigorous physical activity per week are not eligible No inflammatory breast cancer PATIENT CHARACTERISTICS: Inclusion criteria: Hemoglobin ≥ 10 g/dL (patients with a hemoglobin of < 10 g/dL may be retested in 6 weeks after treatment of anemia and allowed to participate in study if blood counts recovered) Physically able to fully participate in yoga intervention Exclusion criteria: Inability to comfortably get up and down from the floor 2-3 times in a session Breathing problems requiring use of oxygen Problems walking without a cane or walker assistance Prior knee or hip replacement with limited movement in the joint Inability to comfortably lie on the stomach Alcohol, or drug abuse Diagnosis of any of the following conditions: Diabetes Chronic obstructive pulmonary disease Uncontrolled hypertension Evidence of liver or kidney failure Symptomatic ischemic heart disease Significant visual or auditory problems Mental disorder or cognitive impairment Notable serious cardiovascular history (e.g., prior life-threatening abnormal heart rhythms) Other medical conditions involving the immune system such as autoimmune and/or inflammatory diseases including rheumatoid arthritis and ulcerative colitis History of breast or any other cancer, except basal or squamous cell skin cancer PRIOR CONCURRENT THERAPY: See Disease Characteristics No regular use of medications with major immunological consequences (e.g., steroids)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janice Kiecolt-Glaser, PhD
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24470004
Citation
Kiecolt-Glaser JK, Bennett JM, Andridge R, Peng J, Shapiro CL, Malarkey WB, Emery CF, Layman R, Mrozek EE, Glaser R. Yoga's impact on inflammation, mood, and fatigue in breast cancer survivors: a randomized controlled trial. J Clin Oncol. 2014 Apr 1;32(10):1040-9. doi: 10.1200/JCO.2013.51.8860. Epub 2014 Jan 27.
Results Reference
result
Links:
URL
http://cancer.osu.edu
Description
The Jamesline

Learn more about this trial

Hatha Yoga in Improving Physical Activity, Inflammation, Fatigue, and Distress in Breast Cancer Survivors

We'll reach out to this number within 24 hrs